This invention relates in general to a light stability apparatus. More particularly this invention relates to an apparatus in which the light sensitivity of various materials, such as pharmaceutically active compounds, is determined by simultaneous exposure of the material to artificial light from all angles, i.e. the materials are bathed in light.
Most pharmaceutical preparations, both solid and liquid, are required by the Food and Drug Administration of the United States Department of Health and Human Services (hereinafter the FDA) to provide in their labeling an "expiration date" after which the preparation may not have the listed potency due to degradation of the active ingredient caused by light or heat. This expiration date is usually found stamped on the preparation labeling or on the package itself.
The expiration date of, for example, a pharmaceutical preparation is most often established by stability testing using guidelines or standards set by the FDA. The stability testing required by the FDA to establish the expiration date of a preparation usually involves light, heat and humidity testing under controlled conditions set forth in FDA rules.
Stability testing is also required by the FDA for New Drug Application (NDA) filing and for ANDA filing and approval. The FDA has recently published a guideline entitled "Stability Testing of New Drug Substances and Products" prepared under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). These guidelines for stability testing appear to require more stringent stability testing than before.
Various manufacturers provide the pharmaceutical industry with cabinets in which to place samples of materials for determining their light and heat stability. These cabinets do not always provide satisfactory data for establishing light and heat sensitivity of materials due to uneven exposure over long periods of time, and improvements in cabinet design and function are necessary.